Trial reportThe Journal of infectious diseases2022
A Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults.
Trial report in The Journal of infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03572062 (A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND,DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF AN ADJUVANTED RESPIRATORY SYNCYTIAL VIRUS), which is not on this map. Cited by 34 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 1/2, placebo-controlled, randomized, observer-blind,dose-finding, first-in-human study to describe the safety, tolerability, and immunogenicity of an adjuvanted respiratory syncytial virus (rsv) vaccine in healthy older adults
Who cites it
34 citing papers in PubMed, 3 syntheses or guidelines pooled it, 45 citations in OpenAlex.
- Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis.CPT: pharmacometrics & systems pharmacology · 2026Pooled it
- Efficacy and safety of respiratory syncytial virus vaccines.The Cochrane database of systematic reviews · 2025Pooled it
- Efficacy, immunogenicity and safety of respiratory syncytial virus prefusion F vaccine: systematic review and meta-analysis.BMC public health · 2024Pooled it
- Immunogenicity, safety, and tolerability of a β-glucan-CpG-adjuvanted respiratory syncytial virus vaccine in Japanese healthy participants aged 60 to 80 years: A phase 2, randomized, double-blind, dose-finding study.Human vaccines & immunotherapeutics · 2025Trial
- Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination.The Journal of infectious diseases · 2024Trial
- Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion Maternal Vaccine Coadministered With Diphtheria-Tetanus-Pertussis Vaccine: A Phase 2 Study.The Journal of infectious diseases · 2024Trial
- A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Single Vaccination of Ad26.RSV.preF-Based Regimen in Japanese Adults Aged 60 Years and Older.Influenza and other respiratory viruses · 2024Trial
- Safety and Immunogenicity of Bivalent RSVpreF Vaccine Coadministered With Seasonal Inactivated Influenza Vaccine in Older Adults.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- Vaccinations in patients with interstitial lung diseases: a narrative review.European respiratory review : an official journal of the European Respiratory Society · 2026Review
- Adult RSV Vaccination: What Is the Role of RSV Subgroup in Disease Prevention?Infectious diseases and therapy · 2026Review
- Bivalent RSV prefusion F vaccination elicits effective neutralization of contemporary and monoclonal antibody-resistant RSV strains.NPJ vaccines · 2026Article
- Bivalent RSVpreF Subunit Vaccine Safety and Immunogenicity in Seropositive 2-<18 Year Olds.Vaccines · 2026Article
- High seroprevalence and high risk: why are older adults more prone to respiratory syncytial virus?Journal of virology · 2025Review
- Article
- Vaccine Development for Human Pneumoviruses.Vaccines · 2025Review
- Immunogenicity of RSV Fusion Protein Adsorbed to Non-PathogenicBiomedicines · 2025Article
- Adult Vaccine Coadministration Is Safe, Effective, and Acceptable: Results of a Survey of the Literature.Influenza and other respiratory viruses · 2025Review
- Development, Current Status, and Remaining Challenges for Respiratory Syncytial Virus Vaccines.Vaccines · 2025Review
- Vaccine and therapeutic agents against the respiratory syncytial virus: resolved and unresolved issue.MedComm · 2024Review
- A self-amplifying RNA RSV prefusion-F vaccine elicits potent immunity in pre-exposed and naïve non-human primates.Nature communications · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRespiratory syncytial virus (RSV) is an important cause of disease in older adults. We evaluated the safety and immunogenicity of a stabilized RSV prefusion F subunit (RSVpreF) vaccine candidate with/without adjuvant in adults aged 65-85 years.
methodsPrimary cohort participants were equally randomized to 1 of 7 RSVpreF formulations: 60 µg with either Al(OH)3 or CpG/Al(OH)3, 120 µg with either Al(OH)3 or CpG/Al(OH)3, 240 µg with either Al(OH)3 or CpG/Al(OH)3, 240 µg unadjuvanted, or placebo, administered concomitantly with high-dose seasonal inactivated influenza vaccine (SIIV). Participants in the month 0,2 cohort were randomized to RSVpreF 240 µg with CpG/Al(OH)3 or placebo, administered at months 0 and 2.
resultsAll RSVpreF vaccine candidates elicited robust and persistent serum neutralizing responses when administered alone or with SIIV. There was no notable difference in neutralizing response between the formulations, including those containing CpG. In the month 0,2 cohort, there was no booster effect of dose 2. SIIV responses were similar or slightly lower with concomitant administration of RSVpreF. Most systemic and local reactions were mild and more frequent after RSVpreF than placebo.
conclusionsRSVpreF formulations were well tolerated and elicited robust neutralizing responses in older adults; however, CpG/Al(OH)3 did not further enhance responses. Clinical Trials Registration. NCT03572062.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.